Class II — XTANT Medical Holdings, Inc
| Recalling firm | Xtant Medical Holdings, Inc. |
|---|---|
| Registered facility | Xtant Medical Holdings, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. |
| Product | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc |
| Quantity | 225 |
| Distribution | US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI. |
| Initiated | 2026-03-09 |
| Classified | 2026-04-21 |
| Recall number | Z-1897-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — XTANT Medical Holdings, Inc (Z-1897-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98643/
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